BridgeMD
A Study to Assess the Use of Methylone in the Treatment of Post-Traumatic Stress Disorder (PTSD)
EU CTIS ID: 2023-505874-14-00
What this study is testing
PART A: To assess the safety and tolerability of oral methylone administered weekly over 4 weeks in participants with PTSD. PART:B: To assess the efficacy of methylone in treating PTSD symptoms.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months. (The PTSD diagnosis will be confirmed at Baseline by the central rater).
- CAPS-5 score of ‚ ≥35 at Screening and ≥28 at Baseline.
- Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
- Proficient in reading and writing in local language sufficient to complete questionnaires.
- Free from any other clinically significant illness or disease
You likely can't join if
- Primary diagnosis of any other DSM-5 disorder
- Body mass index (BMI) <18 kg/m2 or ‚≥40 kg/m2
- Smokes an average of >10 cigarettes and/or e-cigarettes per day
- Uncontrolled hypertension at Screening
- Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
- Use of an SSRI or other antidepressant within 8 weeks of screening
See the full eligibility criteria
- Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months. (The PTSD diagnosis will be confirmed at Baseline by the central rater).
- CAPS-5 score of ‚ ≥35 at Screening and ≥28 at Baseline.
- Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
- Proficient in reading and writing in local language sufficient to complete questionnaires.
- Free from any other clinically significant illness or disease
- Primary diagnosis of any other DSM-5 disorder
- Body mass index (BMI) <18 kg/m2 or ‚≥40 kg/m2
- Smokes an average of >10 cigarettes and/or e-cigarettes per day
- Uncontrolled hypertension at Screening
- Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
- Use of an SSRI or other antidepressant within 8 weeks of screening
- Current or previous history of clinically significant cardiovascular/cerebrovascular conditions
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.